Osteopathic Manipulative Treatment in Oncology Patients' Management
Pain and Quality of Life Management in Oncology Geriatric Patients With Osteopathic Manipulative Treatment: a Pilot Study
1 other identifier
interventional
23
0 countries
N/A
Brief Summary
The aim of present study was to study the osteopathic manipulative effects on pain relief and quality of life improvement on hospitalized oncology geriatric patients. A non-randomized comparison trial was performed in Unit of Oncology Rehabilitation, Palazzolo Institute, Don Carlo Gnocchi Foundation ONLUS, Milan, Italy, from September 2015 to March 2016. 23 older oncology patients were unrolled and allocated in two experimental groups: study group (OMT group, N=12) underwent to osteopathic manipulative treatment associated to physiotherapy and control group (PT group, N = 11) underwent only physiotherapy. At enrollment (T0), 23 recruited oncology patients completed the socio-demographic forms and were evaluated, from external examiner, pain intensity and quality of life. All patients were revaluated at the end of treatment (T4) for quality of life and every week (T1, T2, T3 and T4) for pain intensity. Standard level of significance was p\<0.05.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 28, 2017
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedMay 5, 2017
May 1, 2017
3 months
April 28, 2017
May 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain
Numeric Rating Scale (NRS) is a validated scale to measure the intensity of pain, with numbers between 0 and 10, with 0 representing absence of pain and 10 the worst possible pain experienced by the patient.
Once a week for a total 4 weeks
Secondary Outcomes (1)
Quality of life
At baseline and up to 4 weeks.
Study Arms (2)
OMT group
EXPERIMENTALOsteopathic manipulative treatment
Control Group
ACTIVE COMPARATORPhysiotherapy
Interventions
Eligibility Criteria
You may qualify if:
- oncology patients
- male and female
- age≥65 years
- with a clinical prognosis of 6-24 months
- diagnosis of multifactorial hyperkinetic syndrome (i.e. metastatic surgery)
- pain intensity score higher than 3, measured with Numeric Rating Scale (NRS)
You may not qualify if:
- patients were receiving chemotherapy or radiotherapy treatment at the time of the study
- with mental disorders (MMSE\<10)
- the presence of infection
- anticoagulation therapy
- cardiopulmonary disease
- clinical instability post-surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Arienti C, Bosisio T, Ratti S, Miglioli R, Negrini S. Osteopathic Manipulative Treatment Effect on Pain Relief and Quality of Life in Oncology Geriatric Patients: A Nonrandomized Controlled Clinical Trial. Integr Cancer Ther. 2018 Dec;17(4):1163-1171. doi: 10.1177/1534735418796954. Epub 2018 Aug 31.
PMID: 30168356DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chiara Arienti, PhD
IRCCS Don Gnocchi Foundation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
April 28, 2017
First Posted
May 5, 2017
Study Start
September 1, 2015
Primary Completion
December 1, 2015
Study Completion
March 1, 2016
Last Updated
May 5, 2017
Record last verified: 2017-05